On May 14, 2019 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, and through our license to Santen Pharmaceutical Co. Ltd., wet age‐related macular degeneration, reported financial results for the first quarter ended March 31, 2019 (Press release, Tracon Pharmaceuticals, MAY 14, 2019, View Source [SID1234536341]).

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Recent Corporate Highlights

In April, we announced termination of further enrollment into company sponsored trials of TRC105 due to lack of efficacy in the Phase 3 TAPPAS trial evaluating TRC105 in combination with Votrient (pazopanib) in patients with advanced or metastatic angiosarcoma.
"While we were disappointed in the outcome of the TAPPAS interim analysis, we have several other active clinical programs and look forward to developing multiple bispecific antibodies through our broad and long term partnership with I-Mab Biopharma," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are poised to initiate first-in-human dosing of the CD73 antibody TJ004309 and look forward to 2020 when we expect to begin clinical development of the first of up to five bispecific antibodies. We also continue to evaluate companies with first-in-class or best-in-class clinical stage assets who would benefit from accessing our product development platform, which we believe offers a rapid and capital-efficient U.S. drug development solution."

Expected Upcoming Milestones

Dosing of the first patient in a Phase 1 study of TJ004309 as a single agent and in combination with Tecentriq (atezolizumab), a PD-L1 checkpoint inhibitor marketed by Roche, in patients with advanced solid tumors is expected mid-2019.

Publication of TRC253 Phase 1 data in patients with metastatic castrate resistant prostate cancer is expected in the second quarter of 2019.

Top-line data from the randomized Phase 2 AVANTE trial of DE-122 in patients with wet age-related macular degeneration (AMD) are expected in the first half of 2020.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments were $32.1 million at March 31, 2019, compared to $39.1 million at December 31, 2018. We expect our current cash, cash equivalents and short-term investments to fund operations into the third quarter of 2020.

Collaboration revenue was $0 for the first quarter of 2019 compared to $3.0 million for the first quarter of 2018. The decrease was due to the $3.0 million non-refundable upfront payment received in connection with our prior agreement with Ambrx, which was recorded as revenue in the first quarter of 2018.

Research and development expenses for the first quarter of 2019 were $5.2 million compared to $9.4 million for the first quarter of 2018. The decrease was primarily attributable to lower manufacturing expenses for TRC105 in the first quarter of 2019 as compared to the 2018 period.

General and administrative expenses for the first quarter of 2019 were $1.9 million compared to $1.8 million for the first quarter of 2018.

Net loss for the first quarter of 2019 was $7.2 million compared to $8.4 million for the first quarter of 2018.
Investor Conference Call

The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its first quarter 2019. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 9290299. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About DE-122 (carotuximab)

DE-122, a novel ophthalmic formulation of carotuximab, is active in preclinical choroidal neovascularization (CNV) models and designed to enhance the effect of approved VEGF inhibitors used to treat wet AMD. DE-122 is being investigated in the Phase 2 randomized AVANTE trial assessing the efficacy and safety of intravitreal injections in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F877L mutation. The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. TRC253 is currently being studied in a Phase 1/2 clinical trial in prostate cancer. For more information about the clinical trial, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in a Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On May 14, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the UBS Global Healthcare Conference on Wednesday, May 22nd, 2019, at 9:00 a.m. EDT (Press release, Bio-Techne, MAY 14, 2019, View Sourcenews/detail/138/bio-techne-to-present-at-the-ubs-global-healthcare-conference" target="_blank" title="View Sourcenews/detail/138/bio-techne-to-present-at-the-ubs-global-healthcare-conference" rel="nofollow">View Source [SID1234536925]). The conference will be held at the Grand Hyatt Hotel in New York City.

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A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link https://protect-us.mimecast.com/s/H5PbCR6MPEIgkMNru9JEaM?domain=cc.talkpoint.com.

On May 14, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with an initial focus on Myelodysplastic Syndromes (MDS), reported financial results for the first quarter of 2019 ended March 31, 2019 (Press release, Onconova, MAY 14, 2019, View Source [SID1234536271]).

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"As we progress through 2019, we are advancing the clinical development of our pipeline and executing on our collaboration strategy, as highlighted by the recently announced license agreement for investigational rigosertib in Greater China with HanX Biopharmaceuticals (HanX)," said Steven M. Fruchtman, M.D., President and Chief Executive Officer. "2019 is an important year for Onconova and we are working diligently to execute on our objectives. If successful, we believe rigosertib could be the first new treatment for higher-risk MDS (HR-MDS) in more than 15 years."

Dr. Fruchtman added, "Enrollment in our Phase 3 intravenous (IV) rigosertib trial in second-line HR-MDS patients is continuing and is our top priority. We exceeded 75 percent enrollment of the study during the first quarter and are focused on completing enrollment in the second half of 2019 and reporting top-line data following full enrollment and 288 death events. We believe the addition of sites in Brazil and China later this year could contribute significantly to achieving our goal of completing enrollment by year end. We also look forward in the future to initiating a Phase 3 trial with oral rigosertib in combination with azacitidine in first-line HR-MDS patients and to filing an IND in the U.S. for ON 123300, a first-in-class CDK4/6 + ARK5 inhibitor for the treatment of a variety of advanced tumors."

First Quarter 2019 and Recent Highlights

Entered into rigosertib license agreement with HanX for the development and commercialization of rigosertib in Greater China, which, together with an equity investment at a premium, brings $4 million in cash to the Company. This new HanX license expands the existing collaboration between the two companies. Onconova and HanX previously signed a separate agreement in December 2017 for the pipeline compound ON 123300, Onconova’s novel CDK 4/6 inhibitor, which is expected to enter a Phase 1 clinical trial in the U.S. during the second half of 2019.
Achieved over 75 percent enrollment in the INSPIRE study during the first quarter, and remain focused on completing enrollment in the second half of 2019 and reporting top-line data following full enrollment and 288 death events.
More than 140 trial sites in 23 countries across four continents are open, including 21 sites in Japan. Opened 19 new clinical trial sites in 8 already participating countries to support completion of enrollment of 360 patients in the Phase 3 INSPIRE study. Additional geographies are being opened during the coming months to add approximately 25 more sites.
Attended MDS Symposium in Copenhagen May 8-11, 2019, for which five posters related to rigosertib were accepted for presentation.
Oral Rigosertib in Combination with Azacitidine for First-Line HR MDS Trial Progress and Near-Term Milestones

In December 2018, Onconova submitted an application for a SPA to the FDA for a Phase 3 Trial of oral rigosertib in combination with azacitidine for treatment of first-line higher-risk MDS adult patients. The Company is currently in discussions with the FDA regarding the SPA. Upon agreement regarding the SPA, Onconova hopes to initiate the Phase 3 study with the support of a partnership.
Business Development Progress for Rigosertib and Pipeline Products

Onconova entered into a new license agreement with HanX to develop and commercialize rigosertib in Greater China. HanX is a China-based pharmaceutical company focused on the development, registration, and commercialization of therapeutics for China. Under the terms of the agreement, Onconova has granted to HanX an exclusive license to develop and commercialize rigosertib in Greater China. In exchange for these rights, HanX will pay a $2 million up-front payment and make an additional $2 million equity investment in Onconova stock at a premium to market. In addition, HanX will initially dedicate $2 million in local currency to fund rigosertib development in China over the next two years and will be responsible for future development costs of the product in China pursuant to a joint development plan. HanX will make additional regulatory, developmental, and sales-based milestone payments to Onconova of up to $45.5 million and pay Onconova tiered royalties up to double digits on net sales in Greater China. If approval is received, Onconova will supply the finished product to HanX for development and commercialization. HanX also will support Onconova’s other clinical trial initiatives in Greater China.
ON 123300, an investigational first-in-class dual inhibitor of CDK4/6 + ARK5 with the potential to treat a variety of cancers, continues to make progress toward clinical development in the U.S. and China in partnership with HanX. HanX has conducted toxicology studies to support an Onconova IND filing in the U.S., anticipated in the second quarter of 2019.
Collaboration with the National Cancer Institute is ongoing for preclinical studies of rigosertib for treatment of pediatric cancer associated RASopathies.
Scientific presentations related to rigosertib development and clinical trials were made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the MDS Symposium in Copenhagen, and the Acute Leukemia Forum in Newport, CA; upcoming presentations will be made at the Acute Leukemia Forum in China, and the European Hematology Association (EHA) (Free EHA Whitepaper) Congress. Onconova will also attend the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting in June.
First Quarter 2019 Financial Results

Cash and cash equivalents as of March 31, 2019, totaled $10.4 million compared to $17.0 million at December 31, 2018. The Company expects that cash and cash equivalents at March 31, 2019 will be sufficient to fund ongoing trials and operations into the fourth quarter of 2019. After receiving the upfront proceeds from the HanX rigosertib transaction, the Company expects that its cash and cash equivalents will be sufficient to fund ongoing trials and operations into the first quarter of 2020.

Net loss was $7.6 million for the quarter ended March 31, 2019, compared to $5.1 million for the first quarter ended March 31, 2018. Research and development expenses were $4.1 million for the quarter ended March 31, 2019, and $4.6 million for the comparable period in 2018. General and administrative expenses were $3.2 million for the quarter ended March 31, 2019, and $1.9 million for the comparable period in 2018.

Conference Call and Webcast Information

The Company will host a conference call today, May 14, at 9 a.m. Eastern Time, to provide a corporate update and discuss first quarter 2019 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or internationally (210) 229-8823 and using conference ID: 4275108. The call will also be webcast live. Please click here to access the webcast. A replay will be available following the live webcast.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.

About Onconova Therapeutics, Inc.

Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS). Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are im

On May 14, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (Vote: 12 yes, 3 no, zero abstained) that the demonstrated benefit of pexidartinib outweighs the risks in the treatment of adult patients with symptomatic TGCT, which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery (Press release, Daiichi Sankyo, MAY 14, 2019, View Source [SID1234536292]).

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"Today’s vote in favor of pexidartinib marks a significant step toward delivering the first approved systemic therapy for select TGCT patients whose disease is not amenable to improvement with surgery," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "Some people living with TGCT experience debilitating symptoms and need innovative treatment options. We believe that pexidartinib has the potential to help address this need by offering carefully selected TGCT patients an important treatment advancement, and we look forward to working with the FDA as it completes its review of our application."

The New Drug Application (NDA) for pexidartinib is currently under Priority Review in the U.S., and the FDA is expected to decide whether to approve the application by the PDUFA date of August 3, 2019. The FDA will consider today’s vote as it reviews the NDA, although it is not obligated to follow the Committee’s recommendation. The NDA submission is based on the results of the pivotal phase 3 ENLIVEN study of oral pexidartinib, the first placebo-controlled study of a systemic investigational therapy in patients with TGCT.

The ENLIVEN study met its primary endpoint of tumor response rate by RECIST, which was 39 percent in pexidartinib-treated patients and zero percent for placebo-treated patients at week 25 (p <0.0001). In the ENLIVEN study, hepatic toxicities were more frequent with pexidartinib versus placebo (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] ≥3X the upper limit of normal [ULN]: 33 percent, total bilirubin ≥2X ULN: 5 percent, N=61). In the randomized Part 1 of the study, eight (13%) patients discontinued pexidartinib due to adverse events (AEs); one discontinuation was due to hypertension and seven were due to liver-related AEs occurring within the first two months of treatment. Of the liver-related AEs, three were serious nonfatal AEs with increased bilirubin, one lasting ~7 months. In non-TGCT development studies using pexidartinib, two severe liver toxicity cases (one required liver transplant, one was associated with death) were observed.

About TGCT (PVNS/GCT-TS)
Tenosynovial giant cell tumor (TGCT), also referred to as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is a rare, non-malignant tumor that can be locally aggressive. TGCT affects the synovium-lined joints, bursae, and tendon sheaths, resulting in swelling, pain, stiffness and reduced mobility in the affected joint or limb.[1],[2],[3]

While the exact incidence of TGCT is not known, it is estimated that the incidence of TGCT is 11 to 50 cases per million person-years, based on studies from three countries.[4],[5],[6] TGCT is subcategorized into two types: localized, which is more common and accounts for 90 percent of cases, and diffuse, which accounts for 10 percent of cases.5,6 The current standard of care for TGCT is surgical resection.1,2 However, in patients with a recurrent, difficult to treat, or diffuse form where the tumor can wrap around bone, tendons, ligaments and other parts of the joint, it is more difficult to remove or might not be amenable to improvement with surgery due to the risk of morbidity and potential recurrence. Additional surgeries for more severe cases can lead to significant joint damage, debilitating functional impairments, and reduced quality of life and amputation may be considered.[7],[8],[9]

Recurrence rates for localized TGCT are estimated to be up to 15 percent following complete resection.2,[10],[11],[12] Diffuse TGCT recurrence rates are estimated to be about 20 percent to 50 percent following complete resection.3,10,[13] TGCT affects all age groups; the diffuse type on average occurs most often in people below the age of 40 and the localized type typically occurs in people between 30 and 50 years old.1,4,5,6

About Pexidartinib
Pexidartinib is an investigational, novel, oral small molecule that potently inhibits CSF1R (colony stimulating factor-1 receptor), which is a primary growth driver of abnormal cells in the synovium that cause TGCT. Pexidartinib also inhibits c-kit and FLT3-ITD. Pexidartinib was discovered by Plexxikon Inc., the small molecule structure-guided R&D center of Daiichi Sankyo.

Pexidartinib is currently under regulatory review with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery. In addition to Priority Review designation, pexidartinib has been granted Breakthrough Therapy designation for the treatment of patients with pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), where surgical resection may result in potentially worsening functional limitation or severe morbidity, and Orphan Drug designation for PVNS/GCT-TS by the FDA. Pexidartinib also has received Orphan Drug designation from the European Commission for the treatment of TGCT. Pexidartinib is an investigational compound that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: [fam-] trastuzumab deruxtecan, an antibody drug conjugate (ADC) for HER2 expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory FLT3-ITD acute myeloid leukemia (AML); and pexidartinib, an oral CSF1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.

On May 14, 2019 KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, reported its corporate and financial results for the quarter ended March 31, 2019 (Press release, KemPharm, MAY 14, 2019, View Source [SID1234536342]).

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"The first quarter of 2019 and early April were highlighted by advancements in our KP415 and APADAZ programs, serving to propel each towards what we believe will be significant value building events in the coming months," said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "For KP415, our prodrug product candidate being developed for the treatment of attention-deficit/hyperactivity disorder (ADHD), we announced the completion of the pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA). We have recently received the minutes from that meeting which confirm the previously reported results. In summary, we believe the review of the KP415 pre-NDA briefing package, which included clinical, non-clinical and human abuse potential study results, as well as regulatory elements, was consistent with our interpretation and previous interactions with the FDA, and, as a result, we believe that we are positioned to submit the KP415 NDA in late second quarter or early third quarter 2019."

"In parallel with the regulatory activities for KP415, we have entered into what we believe are the final stages of the partnering process for our ADHD franchise, which includes KP415 and KP484," continued Dr. Mickle. "Since the initiation of the partnering process, our goal has been focused on securing an agreement with a partner fully dedicated to maximizing the commercial value of KP415 and KP484. While still engaged with multiple parties, we believe that the process should be complete sometime later this quarter or early third quarter."

"With regard to APADAZ, we continue to work with our partner, KVK Tech, to advance several initiatives that we believe will contribute to a successful market introduction of the product. The commercial launch remains on track for the second half of 2019," said Dr. Mickle. "The first quarter was highlighted by three important events. In January, we received FDA approval of two additional dosage strengths of APADAZ. Following that, in February, APADAZ was added to compendia with authorized generic pricing similar to current generics. And most recently, beginning in March, we learned that the ongoing process of formulary adoption of APADAZ and its authorized generic had advanced more rapidly than we anticipated. Notably, according to Managed Markets Insights and Technology estimates, APADAZ, both the brand and authorized generic, is currently being reviewed and added to formularies in various markets including both commercial and Medicaid. Based on this progress and other indicators, we continue to believe that the replacement of current hydrocodone/acetaminophen (APAP) products with APADAZ and its authorized generic has the potential to be a meaningful market opportunity."

Q1 2019 Financial Results:
For the quarter ended March 31, 2019, KemPharm’s reported net loss was $12.3 million, or $0.46 per basic and diluted share, compared to a net loss of $26.2 million, or $1.77 per basic and diluted share for the same period in 2018. Net loss for Q1 2019 was driven primarily by an operating loss of $11.4 million and net interest expense and other items of $1.4 million, partially offset by non-cash fair value adjustment income of $0.5 million. The operating loss of $11.4 million for Q1 2019 was a decrease of $3.4 million compared to $14.8 million in Q1 2018, which was primarily due to decreases of $3.1 million in research and development expenses and $0.3 million in general and administrative expenses, respectively.

As of March 31, 2019, total cash, which is comprised of cash, cash equivalents and restricted cash, was $14.0 million, which was a decrease of $8.4 million as compared to December 31 2018. The decrease in total cash during Q1 2019 was due to a use of cash of $11.1 million, offset by proceeds of $2.7 million on the sale of approximately 1.4 million shares under the equity line of credit with Lincoln Park Capital.

"As we seek to finalize the partnering process for KP415 and KP484, we have utilized a portion of our equity line of credit with Lincoln Park Capital. This additional capital, combined with cost reductions, extends the cash runway further into Q3 2019," said Dr. Mickle. "In addition, we expect that our cash burn rate will reduce substantially following the NDA filing for KP415."

Presentation and Webcast at RBC Capital Markets Global Healthcare Conference:

KemPharm also announced today that Dr. Mickle will present at the RBC Capital Markets 2019 Global Healthcare Conference being held May 21-22, 2019, at the InterContinental New York Barclay.

Details of KemPharm’s presentation are as follows:

Event: RBC Capital Markets 2019 Global Healthcare Conference
Date: Wednesday, May 22, 2019
Time: 1:35 PM (EST)
Room: Morgan Suite
Location: InterContinental New York Barclay, 111 East 48th Street, New York, NY
The presentation will be webcast and available one hour following the live event at http://www.veracast.com/webcasts/rbc/healthcare2019/82314394157.cfm. The replay will be available for 90 days.

In addition, the presentation will be available on the Investor Relations section of the Company’s website at View Source

Recent and Q1 2019 Activities:

Announced Completion of KP415 Pre-NDA Meeting with FDA

On April 11, 2019, KemPharm announced that it concluded a pre- NDA meeting with the FDA for KP415, KemPharm’s investigational attention-deficit/hyperactivity disorder (ADHD) product candidate that contains serdexmethylphenidate (SDX, a prodrug of d-methylphenidate) and d-methylphenidate. At the pre-NDA meeting, representatives from the FDA reviewed KemPharm’s summary of the data package being prepared for the KP415 NDA submission, including clinical, non-clinical and human abuse potential studies, as well as regulatory elements. Based on the feedback from the FDA, the Company believes its regulatory data package will be sufficient for submission, with acceptance of the filing subject to the FDA’s review of the complete package.
Provided Update on APADAZ Formulary Adoption

On March 13, 2019, KemPharm provided an update on formulary adoption of APADAZ, an immediate release combination of KemPharm’s prodrug, benzhydrocodone, and APAP. APADAZ and its authorized generic are currently being reviewed and added to formularies in various markets including Medicaid. KemPharm believes the continued adoption of APADAZ by formularies is another stepping stone in the efforts to prepare APADAZ for commercial launch as soon as the second half of this year.

Announced Enhancements to U.S. and Global Intellectual Property Estate, Including IP Protection for KP415 in Canada, Japan and Korea

On January 29, 2019, KemPharm announced enhancements to its U.S. and global intellectual property estate governing its portfolio of prodrug product candidates. The United States Patent and Trademark Office issued seven (7) new patents to KemPharm during 2018 related to several of its compound families, including KP201, KP303, KP511, KP606 and KP746. In addition, KemPharm has augmented and strengthened the global patent estate for KP415 with the addition of issued patents last year in Canada, Japan and Korea.
Presented Scientific Posters at APSARD’s 2019 Annual Meeting

On January 18, 2019, KemPharm announced that research assessing the oral and intranasal human abuse potential of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), as well as new pharmacokinetic data for KP415, were presented in four posters and one oral "data blitz session" at the 2019 Annual Meeting of the American Professional Society for ADHD and Related Disorders (APSARD).
Announced FDA Approval of sNDA for Two Additional Strengths of APADAZ (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP

On January 7, 2019, KemPharm announced that the FDA approved a Supplemental New Drug Application (sNDA) for two additional strengths of APADAZ. The approval of these new dosage strengths, 4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP, follows the NDA approval on February 23, 2018 of the 6.12 mg benzhydrocodone/325 mg APAP dosage strength of APADAZ.